Closed, fluid-modulating receiving system for the conveyance, modulation, and collection of fluid matter

ABSTRACT

The present invention provides a closed, fluid-modulating receiving system for the conveyance, modulation, and collection of fluid matter from its source. The receiving system may be employed under both in vivo and inanimate use conditions for the collection and disposal of fluids which may be infectious, hazardous, or toxic in and of themselves.

CROSS-REFERENCE

The present application is a Continuation-In-Part of U.S. patentapplication Ser. No. 529,566 filed May 25, 1990 now pending; which is aContinuation-In-Part of U.S. patent application Ser. No. 445,008 filedDec. 4, 1989 now U.S. Pat. No. 5,061,235; which is aContinuation-In-Part of U.S. patent application Ser. No. 142,077 filedJan. 23, 1988 now U.S. Pat. No. 4,885,000; which is aContinuation-In-Part of U.S. patent application Ser. No. 001,648 filedJan. 9, 1987, now abandoned.

FIELD OF THE INVENTION

The present invention is concerned generally with articles and methodsfor removing fluids from various sources; and is particularly directedto receiving systems for the conveyance, modulation, collection, anddisposal of fluid matter from its source under both in vivo andinanimate conditions.

BACKGROUND OF THE INVENTION

In this advanced technological age, the collection and disposal offluids, particularly waste fluids, has become an ever more complexproblem of increased difficulty. In its most general usage, the term"fluid matter" includes not only those substances in a true liquidphysical state but also includes substances in solid physical statewhich are suspended, dispersed, or dissolved in a liquid carrier; aswell as those compositions which exist or have been converted into avaporized or gaseous state. Accordingly, the term "fluid matter"encompasses and denotes any and all of these possible combinations andpermutations.

Much of the difficulty and complexity regarding the collection anddisposal of fluid matter in general and of waste fluid matter inparticular centers and focuses upon what are the proper answers to twodifferent, but directly related, fundamental questions. These are:First, how does one collect and dispose of the fluid matter withouthimself also coming into effective contact with or being detrimentallyaffected by the fluid matter during the collection and disposal process?Second, how does one effectively collect and dispose of the fluid matterwithout concomitantly influencing, contaminating, and/or otherwisealtering the source from which the fluid matter originates? Ironically,a satisfactory answer and resolution to one of these questions willtypically cause a completely unsatisfactory and often intolerable resultwith regard to the other of these inquiries. A very few commonplaceexamples will illustrate the nature and consequences resulting from thelongstanding and recurring conflict between the answers to thesequestions.

Under in vivo conditions, the conflict presented by these fundamentalquestions is well demonstrated by the persons typically admitted into ahospital ward for: a surgical manipulation or incision; relief from anobstruction or constriction in the urogenital tract; or an ileostomy orcolostomy. In the surgical incision instance, a drain is often insertedinto the wound area after the surgical procedure in order to collect anddrain fluid from the wound subsequently. Conventional practice, however,employs drains having completely open ends in which one open end isinserted into the body of the living subject while the other end liesopen and totally exposed to the ambient environment or is superficiallycovered with a simple bandage. Not surprisingly, infection via the drainat the surgical incision site is commonplace; and is recognized as afrequent hazard and consequence of this procedure. Thus, neitherfundamental question is satisfactorily answered, much less mutuallyresolved, by conventional surgical drains and drainage practices. Notonly is the patient (the source) put at risk, but also those personsattending the patient are also unknowingly placed at risk by handlingthe fluid matter discharged from the drainage tube.

A second in vivo example of a failure to satisfactorily answer andresolve the two fundamental questions is the conventional insertion of aurinary catheter through the genital area into the urinary tract of apatient for relief and release of accumulated urine from the bladder.Typically, a urinary catheter remains inserted internally for severaldays; and the usual procedure is for a nurse periodically to irrigatethe catheter with sterile saline over the duration of its use. However,the catheter, from the time of its insertion internally, must remaincompletely open and can not prevent backflow of urine from its externalend; and unavoidably becomes a pathway for potential infections andother medical complications. Here again, the dangers to both patient andattendant nurse caused by the lack of effective answers to the twofundamental inquiries are apparent. While the collection and disposal ofthe urinary fluid is physically easy, the nurse or attendant collectingand handling the discharged urine is at serious risk because of unknownbacteria or other microbes which might be in the urine; similarly, thepatient is at risk by the continuous exposure of his urinary tract tothe presence and possible backflow of urine throughout the entire periodof catheter use.

A third in vivo example is the consequence of a (partial or complete)ileostomy or colostomy from which the person must then use a bag forcollection of fecal matter. The deficiencies of and problems associatedwith the conventional ileostomy/colostomy bag are many and attributableto a failure to adequately answer and effectively resolve the twofundamental questions. These deficiencies and problems include: failuresof the bag to contain and hold the solid, liquid, and gaseous parts ofthe fecal matter released from the bowel; severe leakage and drainageboth from the resected bowel end and from the retaining bag itself; thefrequent infections to the patient at the area of connection between thecolostomy bag and the resected end of the bowel; the fecal exposure andgeneral danger to the person attending or helping the patient withattachment and/or replacement of the colostomy bag; and the generalinconvenience and cumbersome nature of the conventional colostomy bag,its mode of use, and its mode of attachment and disconnection. Not onlyis the patient who must use the bag subject to embarassment, discomfort,and potential infection; often another person aiding the patient is alsoplaced at serious risk by the bag.

Similarly, the two fundamental inquiries apply to a number ofcommonplace situations at home and in the workplace where the collectionand disposal of fluid matter can not be achieved without seriousconsequences or risks to either the person performing the collection offluid or the source of the fluid. Typical examples are the use offormalin and/or formaldehyde in the mortuary and funeral home; and theuse of organic solvents in the dry cleaning industry. Clearly, both ofthese instances involve the use of hazardous and/or toxic fluids inwhich direct exposure whether by direct physical contact or by aircontamination may lead to serious chemical and biological injury. Thus,the person collecting and disposing of these hazardous and/or toxicfluids risks his health (and sometimes his life) if the means employedfor collecting and disposing of these fluids are not safe and assured.Similarly, if the person does not take effective measures to safeguardthe source of these hazardous and/or toxic fluids--recognizing thatthese fluids have beneficial uses and applications--then by haphazardand reckless methods of collection and disposal, the source mayunintentionally and inadvertently become contaminated, chemicallyaltered, or otherwise subjected to undesired change.

It will be recognized and appreciated therefore that the two fundamentalquestions must be answered and resolved without major conflict; and areof primary importance and paramount interest both to the personperforming the task of collecting the fluid and to the source of thefluid matter. The need for an effective system for the collection anddisposal of fluid matter which protects and preserves both the source ofthe fluid as well as the person collecting the fluid is long recognizedand remains today unsatisfied in the main. The development of a generalreceiving, collection, and disposal system which adequately answers andproperly resolves these two fundamental issues would therefore berecognized by persons ordinarily skilled in this field as being a majoradvance and providing highly desirable benefits to the user.

SUMMARY OF THE INVENTION

The present invention provides a closed, fluid-modulating receivingsystem for the conveyance, modulation, and collection of fluid matterfrom its source, said fluid-modulating receiving system comprising:

a conduit for the conveyance of fluid matter, said conduit having aclosed body of determinable dimensions and configuration, an internallumen for the flow of fluid matter, and two discrete open ends, one ofsaid open conduit ends to be positioned in flow communication with thesource of fluid matter;

a discrete, flow-through modulator unit having at least onefluid-modulating element, a flow inlet, and a flow outlet, saidmodulator unit being positioned external to the source of fluid matterand being in closed fluid flow communication with said conduit such thatall fluid matter conveyed from the source by said conduit flows intocontact with and is acted upon by said fluid-modulating element, atleast one identifiable property of said fluid matter being acted upon bysaid fluid-modulating element to yield a resulting fluid product;

a replaceable receiver of determinable dimensions and volume in closedfluid flow communication with said modulator unit for receipt andcollection of said resulting fluid product, the internal volume of saidreceiver being not less than partially filled with at least onesuperabsorbent fibrous material comprising fluid-absorbing fibers ableto absorb at least fifteen times their own weight of liquid, suchresulting fluid product as flows into said receiver being at leastpartially absorbed by said superabsorbent fibrous material.

BRIEF DESCRIPTION OF THE DRAWING

The present invention may be more easily and completely understood whentaken in conjunction with the accompanying drawing, in which:

FIG. 1 is a block diagram illustrating the essential component parts ofthe present invention;

FIG. 2 is an illustration of the preferred construction ofsuperabsorbent fibrous material disposed within the receiver;

FIG. 3 is a magnified cross-sectional view detailing the construction ofsuperabsorbent fibrous material of FIG. 2;

FIG. 4 is an overhead, perspective view of the separated component partsof the drainage fluid receiving system comprising one preferredembodiment of the present invention;

FIG. 5 is another view of the drainage fluid receiving system of FIG. 4as an assembled in vivo system with regard to a living subject;

FIG. 6 is a perspective view of a urinary fluid receiving systemcomprising a second preferred in vivo embodiment of the presentinvention;

FIG. 7 is a perspective view of a resected bowel end and the firstcomponent part of an in vivo fluid fecal matter receiving systemcomprising a third preferred embodiment of the present invention;

FIGS. 8A and 8B are alternate perspective views of the second componentpart of the in vivo fluid fecal matter receiving system of FIG. 7;

FIG. 9 is a frontal view of the third component part of the in vivofluid fecal matter receiving system of FIGS. 7-8;

FIG. 10 is a perspective view of the resected bowel end in position withthe fluid fecal matter receiving system of FIGS. 7-9;

FIG. 11 is an alternative sectional view of the second and thirdcomponent parts of the fluid fecal matter receiving system of FIGS.7-10;

FIG. 12 is a rear view of the fluid fecal matter receiving system ofFIGS. 7-11; and

FIG. 13 is a perspective view of a hazardous/toxic fluid receivingsystem.

DETAILED DESCRIPTION OF THE INVENTION

The present invention is a closed receiving system for the conveyance,modulation, collection, and subsequent disposal of fluid matter from itssource. The present receiving system is unique in its requisiteessential component parts; and is unusual in its ability to receive andcollect fluid matter comprising gaseous, liquid, and even solidmaterials in a manner which protects the user from the fluid matter andconcomittantly protects the source of the fluid matter fromcontamination or exposure to persons or the ambient environment. Amongthe many benefits and advantages thus provided by the present inventionare the following:

1. The receiving system of the present invention after assembly is acompletely closed system for the protection of both persons and thesource of the collected matter. The assembled receiving system remainsclosed at all times whether or not the system is in actual use; andremains a closed system even after the fluid matter has been receivedand collected for disposal. Due to the closed nature of this receivingsystem, neither the source of the fluid matter initially, nor the meansby which the fluid matter is conveyed, nor the received and collectedfluid matter ready for disposition lies exposed to the ambientenvironment at any time.

2. The receiving system of the present invention collects the fluidmatter and combines the collected fluid matter with at least onesuperabsorbent fibrous material comprising fluid-absorbing fibers ableto absorb not less than 15 times their own weight of liquid.Accordingly, such fluid matter as flows into the system is collected andbecomes at least partially if not entirely absorbed by thesuperabsorbent fibrous material. The absorbance of the fluid matter inthis manner eliminates the usual problems of liquid pressures, surges,sloshing, and the like encountered using conventional collection andstorage apparatus; and provides for an easier and more convenientdisposition of the absorbed fluid matter without fear of liquid leakage.

3. The closed receiving system comprising the present invention may beemployed as a temporary mode of fluid collection or used as apermanently installed fixture for long-term service. Accordingly, thereceiving system in any of its various embodiments may be employed foronly a few hours or a few days, or alternatively for an indefinitenumber of years. The system provides for a replaceable receiver ofvariable dimensions, configuration, and volume to be positioned inclosed fluid-flow communication with the source of the fluid matter. Thereceiver, being not less than partially filled with at least onesuperabsorbent fibrous material comprising fluid-absorbing fibers, isable to absorb at least 15 and often 60-100 times their own weight ofliquid. The system as a whole permits replacement of the receiver asdesired or necessary; and typically maintains the remainder of thesystem in a closed condition during the time required to replace onereceiver unit with another. Therefore, whether the receiving system isemployed only on a temporary basis or as a permanently installed system,the conveyance, modulation, and collection of fluid matter from itssource can continue effectively.

4. The receiving system of the present invention can take form in manydifferent embodiments and optionally includes many desirable featuresand conveniences for the user. Regardless of the complexity of theembodiment and despite the many diverse forms and constructions whichmay be employed in the system, only three component parts are requiredfor and essential to the receiving system in order to be both operativeand effective. The diversity of embodiments and formats is clearlyintended to satisfy and comply with the needs and/or desires of theindividual use; and the many alternative forms and applications for thepresent receiving system are purposely intended and knowingly expectedto be divergent and radically remote from one another as often as theyare similar. Thus, the closed receiving system has no restrictions orlimitations whatsoever regarding its physical design and construction,place and mode of application, or intended use and function beyond thoseminimal requirements noted herein.

5. The present receiving system is desirably employed in a variety ofdifferent in vivo applications and settings for the removal of fluidmatter from the body of a living subject, human and animal. Merelyillustrative of the diversity of in vivo embodiments for the presentinvention are the system for receiving drainage fluid from a surgicalincision in a living subject; the system for receiving fluid from theurinary tract in a living subject; and the system for receiving fluidfecal matter from a resected bowel in a living subject after ileostomyor colostomy. In addition, due to the intended range and variety of invivo usages and applications, the entirety of the present receivingsystem may be prepackaged and/or presterilized prior to use; andemployed alternatively as a temporary or as a permanent receiving systemin vivo as required.

6. The present receiving system may also be advantageously employed withinanimate articles and non-living equipment for the receipt andcollection of fluid matter. Under such use circumstances, theembodiments of the receiving system may be either larger or smaller insize and volume; employ resilient and long-wearing materials such asrefractory metals and plastics; and typically be employed in thecollection and disposal of waste, hazardous, and/or toxic fluids whichare known or are suspected of being foul, dangerous, or lethal to livinghumans and animals. The embodiments described hereinafter are merelyexemplary and illustrative of temporary and permanent receiving systemsfor the receipt, collection, and subsequent disposal of waste,hazardous, and/or toxic fluids.

7. The receiving system of the present invention permits and optionallyprovides for chemical reactive contact, chemical modification and/orchemical alteration of the fluid matter while within the confines of thesystem as part of its ultimate receipt and collection. The site ofchemical reaction and modification within the closed receiving systemmay be varied as the needs or desires of the user demand. Nevertheless,regardless of the site or precise positioning within the closedreceiving system, the fluid matter being conveyed and subsequentlyreceived and collected can optionally be combined with a variety ofreactive chemical substances such as initiators, activators,neutralizers, anti-microbial agents, enzymes, dye reagents, and thelike. The chemical composition and formulation, structure, chemicalattributes, affinity for specific compounds, and activity properties forthe individual chemical compositions (including gaseous, liquid, andsolid materials) comprising the fluid matter may be substantiallyaltered, modified, and changed in greater or lesser degree during thetime required for passage of the fluid material from its source to finalreceipt and collection. Thus, under in vivo applications andcircumstances, the collected fluid matter may optionally be combinedwith germicidal agents to reduce or eliminate the potential infectivityof the fluid; and/or with chemical initiators or activators to reducethe nature or chemical activity of the fluid matter; and/or withchemical neutralizing agents to retard or eliminate the corrosive orpervasive chemical properties of the fluid matter. The assembledreceiving system, being closed to the ambient environment, allows evenfor major chemical reaction and alteration of waste, hazardous, and/ortoxic fluid substances in a controlled and safeguarded manner such thatthe collected fluid presents a greatly reduced risk and danger duringultimate disposition.

It will be recognized and appreciated therefore that the receivingsystem which is the subject matter as a whole comprising the presentinvention may take physical form in many different embodiments andconstructions; and is useful and effective for the receipt andcollection of fluid matter in a variety of radically remote anddivergent applications and use formats. Thus, in order to provide aclear, complete, and comprehensive understanding of the presentinvention, the detailed description will be presented hereinafter asfollows: a detailed review and disclosure of the individual componentparts comprising the present invention which are required and essentialin each and every embodiment of the receiving system; three differentpreferred embodiments of the present invention illustrating the range ofintended uses and applications under in vivo conditions; and anadditional preferred embodiment of the present receiving systemexemplifying the range of intended uses under inanimate/non-livingconditions for the receipt and collection of waste, hazardous, and/ortoxic fluid matter.

I. THE REQUIRED AND ESSENTIAL COMPONENT PARTS OF THE RECEIVING SYSTEM

The present invention comprising a closed receiving system for theconveyance, modulation, collection, and subsequent disposal of fluidmatter from its source is illustrated by FIG. 1 in block schematic form.The closed receiving system 10 as an assembled whole is comprised ofonly three essential components: a conduit 12 for the conveyance offluid matter; a discrete, flow-through modulator unit 14 having at leastone fluid-modulating element; and a replaceable receiver 16. As shown byFIG. 1, the source of the fluid matter is in closed fluid flowcommunication with the conduit 12, with the modulator unit 14, and withthe receiver 16. Thus, regardless of the true dimensions, configuration,volume, capacity, materials, or nature of fluid-flow linkage among therequisite component parts, the receiving system 10 schematicallyillustrated by FIG. 1 provides a closed, in-line, and dead-ended channelof uninterrupted fluid flow between the source of fluid matter initiallyand the receiver 16 for the collection of fluid at the terminus. Adetailed disclosure and description of each essential component partfollows:

A. The Conduit

The conduit is an essential component required for enabling theconveyance of fluid matter from its source. The conduit, by definition,serves either or both of two functions and capabilities for the systemas a whole. The first function and capability is as a tangible carrierwhich is in physical contact with the fluid matter and itself carriesand conveys the fluid matter directly. The additional or alternativefunction and capability for the conduit is to serve as a structuralconnector or link without which the physical passage or transfer offluid matter from the source would not otherwise occur. The conduitcomprises a closed body of determinable dimensions and configuration forthe flow of fluid matter and has two discrete open ends. One open end ofthe conduit is to be positioned in flow communication with the source offluid matter; the other open end is disposed in fluid-flow communicationwith the modulator unit.

The primary, although not necessarily exclusive, purpose and functionfor the conduit is to convey fluid matter from the source to themodulator unit; and accordingly one open conduit end must be able to bepositioned in either direct or indirect flow communication with thesource of fluid matter. The nature and mode of positioning from an openconduit end with the source of fluid matter will vary greatly with thesource itself and the nature of the fluid matter to be conveyed. Thus,the open end of the conduit may in some circumstances actually beinserted into the source itself; under other conditions the open conduitend will surround the source of fluid matter; and, in othercircumstances, the open conduit end will merely lie adjacent to or abuttan area or zone in which the fluid accumulates at its source. This iscommonly the case under in vivo conditions as exemplified by theembodiments described hereinafter.

The other open end of the conduit is in closed fluid flow communicationwith the modulator unit and, in some meaningful degree, lies external tothe source of fluid matter. It will be recognized and appreciated alsothat the essential requirement is only that the open conduit end be influid flow communication rather than be in direct contact or physicaljuncture with the modulator unit as such. Thus, it is optionallyavailable to the user of the present receiving system to introduce andposition one or more extraneous articles or apparatus between theexternal or remote open end of the conduit and the modulator unit whichmust ultimately be in-line and in flow communication with the conduititself. Whether or not there are intervening articles or apparatuspositioned between the conduit and the modulator unit is of noimportance or consequence to the present receiver system so long as nolongstanding or substantive obstruction/interruption in the flow offluid occurs; and so long as there is no loss of closure or continuityin the fluid flow communication between the conduit and the modulatorunit.

Accordingly, it will be recognized and appreciated that the length, sizeor diameter of internal lumen, configuration, or fluid carrying volumecapacity for the conduit is of little consequence or importance. Manydifferent modes of construction and a diverse range of materials areavailable for making the conduit. Thus, for expected in vivo uses andapplications, the conduit typically will be a small or closed tubeformed of elastic and flexible materials which can be subjected to heator steam sterilization without major loss of cohesive properties ortensile strength. Alternatively, under non-living or inanimate useconditions, the conduit may be formed of highly durable and chemicallyresistant metals or plastics; be of relatively large bore to providelarge volume carrying capacity of fluid; and be of rigid and inflexibleconstruction able to withstand relatively high hydraulic pressure andhigh fluid velocity rates. Clearly, many different and divergentembodiments for the conduit are intended and expected; all of these aredeemed to be within the scope of the present invention.

B. The Modulator Unit

The second, essential component part of the present receiving system isa flow-through modulator unit having at least one fluid-modulatingelement, a flow inlet, and a flow outlet. The modulator unit illustratedby FIG. 1 in schematic form is positioned external to the source offluid matter; and is in closed, fluid flow communication with the remoteopen end of the conduit such that all fluid matter conveyed from thesource by the conduit flows into contact with and is acted upon by thefluid-modulating element of the unit to yield a resulting fluid product.Thus, there are two characteristics and functions required of themodulator unit at a minimum: first, that the modulator unit lie inflow-through fluid communication with the source such that the fluidmatter conveyed by the conduit also flows into and subsequently flowsout of the modulator unit in a generally uninterrupted, closed flowcondition. Second, that fluid matter entering the modulator unit flowsinto contact with and be acted upon at least one fluid-modulatingelement whereby at least one identifiable property of the fluid matterbecomes acted upon by the fluid-modulating element to yield a resultingfluid product. This latter function and property of the modulator unitis unusual feature and thus deserves special descriptive attention anddetail.

The Fluid-Modulating Element

The nature, format, and construction of the fluid-modulating element isintended and expected to be as diverse as the prospective applicationsand usages for the receiving system as a whole. The fluid-modulatingelement may be constructed as a single article of manufacture; or,alternatively, comprise a plurality of different articles and apparatusin combination. The action and effect of the fluid-modulating elementupon the fluid matter may be gradual or rapid; chemical or physical;subtle or drastic; immediate or delayed; and substantive or trivial.

There are several purposes, results, and consequences characteristic ofand associated with the diverse embodiments of the fluid-modulatingelement. These include: first, the modulating element must make at leastphysical contact (with or without concurrent chemical contact) with thefluid matter passing through the unit; accordingly, it is demanded thatthe modulating element lie in or be disposed in position for at leastphysical continuity and contact with the flow of fluid matter as itpasses through the modulator unit. Second, while the modulating elementmay to some measurable degree retard or reduce the velocity and rate atwhich the fluid matter passes through the modulator unit, there can beno severe obstruction or effective interruption of fluid flow as suchcausing substantial or complete blockage of fluid flow through themodulator unit; the demand for fluid flow communication in asubstantially unobstructed and meaningfully unhindered manner mustcontinue despite the presence and function of the fluid-modulatingelement. Third, recognizing that the fluid-modulating element must existas a discrete entity or moiety within the totality of the modulator unit(but may be comprised of two or more operative parts or constituents),it is highly desirable that the fluid-modulating element provide andmaintain the closed integrity of the receiving system in a manner thatthe ambient environment can not pass through the entirety of thefluid-modulating element; and thus the ambient environment can notdisrupt the closed fluid flow communication between the modulation unit,the conduit, and the source of fluid matter at any time. This optionalattribute is particularly desirable and important in view of thereplaceable nature of the receiver component which ultimately receivesand collects the resulting fluid product after it passes out of themodulator unit. Thus, in these preferred embodiments, even when thereceiver is removed from the system, one or more constituent parts ofthe fluid-modulating element situated within the modulatorunit--optionally but desirably--provide a barrier function; and preventthe ambient environment from entering the system whether or not thereplaceable receiver is then in proper position for fluid flowcommunication. Fourth, as a result of the contact between the fluidmatter entering the modulator unit and the fluid-modulating element, atleast one identifiable property (be it physical, chemical, or otherwise)must be acted upon--but not necessarily be altered by--thefluid-modulating element to yield a resulting fluid product. Thus, therequirement for the fluid-modulating element is only for contact andaction upon the fluid matter; there is no demand and no requirement thatthe identifiable property of the fluid matter being acted uponconsequently be altered, modified, changed, or influenced in any manner,mode, or degree. It should be noted, however, that in many instances andapplications, a chemical reactive contact and result in addition to theminimal physical contact is desirable; and a drastic alteration ratherthan no meaningful modification or change at all, is useful. Under thesealternative circumstances, meaningful changes and substantivemodifications in physical and chemical state will occur. Nevertheless,it will be appreciated that these instances are solely optional as such;and that there is no insistance or necessity that a consequential changein one or more properties of the fluid matter result from the action bythe fluid-modulating element upon at least one identifiable property ofthe fluid matter.

Exemplifying and merely illustrating the range and variety of favoredconstructions for the fluid-modulating element of the modulator unit arethose constructions described subsequently herein. Of these, the porousmatrix layer or filter is most preferred. Such articles areconventionally known and commercially available as porous membranefilters composed of varying compositions such as cellulose,nitrocellulose, nitroacetate, metals, clays, crystals, as well as manymore complex organic and inorganic substances. Such porous membranesprovide a wide range of pore sizes, total pore volume or void volumecapacity, and diverse surface characteristics. Alternative formulationsof porous filters also include amorphous porous glass filters andsilicates, refractory ceramic fibers and mineral mixtures, and plasticsconstructed as various nettings, weaves, and textiles; as well as othercloths, fabrics, and constructions of porous nature. Often, it isdesireable to employ a plurality of these porous filters or matrixlayers in series as a stack of variable thickness; and to intermixdifferent compositions of materials within each of the individual porousmatrix layers so as to provide a range of different properties for eachlayer in the stack of filters. All of these porous matrix layers andfilter materials in individual format or in multi-layer combinations areconventionally known and used; all of these are therefore deemed to bewithin the scope and construction for the fluid-modulating element.

Another favored construction and format for the fluid-modulating elementis the conventionally known, unidirectional flow valve which allows afluid to pass through while prohibiting backflow of fluid in theopposite direction. Such unidirectional flow valves, commonly called"check" valves, are conventionally available in varying constructionsand formats. Most preferred is the cylindrical housing whose internaldiameter contains a plurality of individual blades or leaves whichoverlap one another, each blade or leaf being rotably joined to theinterior walls of the cylinder housing. Thus, fluid entering thecylinder housing pushes and rotates the blades into a flattened positionthereby allowing the fluid to pass through the cylinder, while anyattempted backflow of fluid in the opposite direction raises theindividual leaves into the flow pathway to form an integral wall ofinterlocking leaves which effectively prevents fluid movement in thereturn direction. Clearly, many other constructions and formats of suchunidirectional flow valves are conventionally known and commerciallyavailable. Moreover, it is most desireable that the unidirectional flowvalve be employed in combination with the porous matrix layer or filtermaterial.

It is deemed that a variety of far more complicated and elaborateconstructions for a fluid-modulating element can and will be prepared tomeet specific use circumstances and applications. Accordingly,regardless of the complexity of design or the nature of the materialsused for construction and without regard to whether the modulatingelement is a single, discrete article or composed of a plurality ofdifferent constituent parts, so long as the essential functions andpurposes as delineated above are fulfilled and achieved, that particulardesign and construction lies within the scope of the present invention.

Optional Chemical Constituents For Inclusion Within The Fluid-ModulatingElements

While the minimal demand and requirement for the fluid-modulatingelement of the modulator unit is that physical contact be made with theflowing fluid matter and that at least one identifying property of thefluid matter be acted upon (but not necessarily altered) by thefluid-modulating element to yield a resulting fluid product, it isoptionally available and often highly desireable that one or morechemically active substances be added to and combined with the minimalconstituents comprising the fluid-modulating elements. Although thepresent receiving system as a whole permits the user to positionchemically active substances or articles at any location within theclosed, flow-through system from the conduit to the replaceablereceiver, the modulator unit generally and the fluid-modulating elementin particular are highly favored locations for the addition/inclusion ofchemical reagents and reactants.

Clearly, the range and diversity of chemical compositions suitable foruse as chemical reactants and reagents is huge; and includes all of theconventionally known organic and inorganic compositions of matter aswell as their attributed properties, characteristics, and reactions asconventionally known and recognized in the scientific literature. Thevariety of chemical reagents and reactants therefore includes:initiators; activators; functional and radical groups and moieties; theconventionally known acids and bases; as well as all the classes ofchemical compounds generally known and understood. The kinds andcategories of compositions would therefore include catalysts; enzymes,substrates, and cofactors; specific binding entities such as antibodiesand antigens; as well as non-specific cross-linking substances such asmonomers, homopolymers, and copolymers. The range of desired results andconsequences caused by the presence of such chemical reagents andreactants could thus provide germicidal properties; toxic reductionproperties; inactivation and/or neutralization; and biological orpharmacological potency loss--among others. Clearly, therefore, thechoice of which chemical substance to include as an optional constituentof the fluid-modulating element thus will be controlled and decided bythe user and by the desired result. This is clearly shown by anillustrative example.

For descriptive and illustrative purposes alone, a favored embodimentfor the fluid-modulating element is employed--a porous matrix layer orfilter membrane. Such porous matrices have a plurality of external andinternal surfaces through the thickness of the matrix layer; and providea far greater surface area for deposition and attachment of one or morechemical compositions for subsequent reactive contact with the fluidmatter passing therethrough. The choices of which chemical substances toemploy become dictated by the intended application for the receivingsystem as a whole. For example, with in vivo applications of thereceiving system for drainage of fluid matter from a surgical wound orincision, it is highly desireable to deposit a broad germicidal agentsuch as a phenolic compound or an iodine containing substance directlyonto the external and internal surfaces of the porous matrix layer.Moreover, if the drainage fluid from the surgical wound or incision issuspected of carrying infectious bacteria, a variety of selectiveanti-microbial agents can be disposed upon the external and internalsurfaces of the porous membrane using conventionally known methods.Alternatively, the user may include a porous material as an additionallayer or membrane directly above or below the porous matrix layerinitially present; and in this manner compel a flow-through of the fluidmatter through the chemical reagents and reactants as a separate andindividual occurrence in addition to the flow-through the primary porousmembrane layer.

It will be recognized and appreciated therefore that a host of chemicalreagents and reactants may be optionally introduced into theflow-through system as discrete compositions and/or articles which comeinto individual reactive contact with the fluid matter as an addition tothe passage of the fluid matter through the fluid-modulating element assuch. Under these alternative flow circumstances, the chemicalsubstances may take physical form within the system as capsules,discrete layers or particles; or as integral articles of manufacturewhich can be periodically replenished if desired. These diverse chemicalformats may be individually supported by an open netting or other poroussupports--the nature, format, and construction of these supportingmaterials being of no consequence or importance so long as the free flowof fluid matter remains substantially unobstructed and unhindered.

C. The Replaceable Receiver

The third and final essential component of the system which is thepresent invention is a replaceable receiver positioned in closed,fluid-flow communication with the modulator unit for receipt andcollection of the resulting fluid product. The receiver is a closedcontainer or receptacle of determinable dimensions and configuration;and has an internal volume which is not less than partially filled withat least one superabsorbent fibrous material comprising fluid-absorbingfibers able to absorb at least 15 times their own weight of liquid.Accordingly, such resulting fluid product as flows from the modulatorunit into the receiver is at least partially, if not completely,absorbed by the superabsorbent fibrous material.

The Physical Format And Construction Of The Replaceable Receiver

It will be recognized that the format, construction, materials,dimensions, configuration, and total volume or capacity for the receiverwill vary with the intended mode of use or application. Typically for invivo applications, the receiver will be of minimal size and volume,portable, and be constructed of flexible materials which can besubjected to heat or steam sterilization without deteriorating. Thus,when formed as a urinary catheter system or as an ileostomy/colostomyreceiving system, the receiver is intended to be frequently replaced andis expected to be portable and small enough to be carried comfortably onone's person. Alternatively, in industrial applications for the receiptand collection of waste, hazardous, and/or toxic fluid matter, thereplaceable receiver will typically take form as chemically resistant 55gallon drums or large volume holding tanks which demand the use ofmechanical equipment for removal. Accordingly, neither the dimensions,volume capacity, construction materials, or manner of construction forthe receiver are of any importance or meaning whatsoever.

It is intended and envisioned, however, that the receiver be replaceableon an ongoing basis as the needs or desires of the user dictate. Thepresent invention therefore expects that: because the receiver must bepositioned in closed, fluid-flow communication with the modulator unitfor receipt and collection of resulting fluid product; and also becausethe receiver is expected to be replaced periodically by necessity ordesire; that the design and construction of the receiver be such that itcomprise means (such as connectors) for achieving and disruptingfluid-flow communication at will with the remainder of the system. It isalso highly desireable that the receiver be constructed with aself-sealing closure and/or a one-way flow valve which effectively sealsthe internal contents of the receiver during those time periods when thereceiver is not directly positioned in fluid-flow communication with themodulator unit. This sealing closure, however, is an optional but highlydesireable feature of the receiver construction.

The Superabsorbent Fibrous Material

The preferred superabsorbent fibrous material filling at least part ofthe receiver's internal volume is illustrated by FIGS. 2 and 3respectively. FIG. 2 shows a perspective view of the superabsorbentfibrous material as a sheet construction. As illustrated, the fibrousmaterial is most desirably formed as a superabsorbent sheet-like layer20 comprising fluid-absorbing fibers able to absorb at least 15 timestheir own weight of liquid. The preferred form and embodiment of thesesuperabsorbent fibers is as a non-woven absorbent batt composed of asubstantially uniform array of superabsorbent fibers 22 (able to absorbnot less than 15 times their own weight of liquid) and support fibers24. While the primary function of the superabsorbent fibers 22 is toabsorb high volumes of liquid, the support fibers 24 interlock with thesuperabsorbent fibers 22 to provide strength and stability for thesuperabsorbent fibrous batt both before and after it is saturated byliquid. The support fibers 24 also provide good absorbent and adsorbentqualities and offer good resiliency when either in wet or dry states. Ingeneral, the superabsorbent fibers 22 typically comprise between 5-50%of the total fiber content for the non-woven absorbent batt.

It will be noted and appreciated that the preferred sheet-like layerconstruction for the superabsorbent fibrous material as described hereinis part of the subject matter described and claimed within copendingpatent application of Conrad A. D'Elia and John D. Hogan, entitled"Superabsorbent Non-woven Fibrous Material," the text of which isexpressly incorporated by reference herein. In addition, the mostpreferred composition and blend of fiber materials to be describedsubsequently also comprises a major part of the above identified,co-pending patent application. Preferably, the superabsorbent fibersemployed in the non-woven absorbent batt within the construction is afiber formed from a blend of heterocyclic carbonate and a copolymer ofmaleic anhydride and isobutylene, as described in U.S. Pat. Nos.4,616,063; 4,705,773; 4,731,067; 4,743,244; 4,788,237; and 4,813,945respectively--the text of which are also individually incorporated byreference herein for their disclosures.

For optimal absorptive function by the non-woven absorbent batt, thesuperabsorbent fibers are mixed with support fibers, preferably usingseveral deniers of polyester. A variety of other materials andcompositions may also be used for the support fibers themselves. Theseinclude: rayon, cotton, polypropylene, nylon, and polyethylene. Thesesupport fibers, regardless of specific composition or materials, shouldinterlock with the superabsorbent fibers, preferably in a nonwovenmanner. In addition, although a great range of percentage content forthe support fibers may be utilized, the percentage ratio of supportfibers typically comprises 50-95% of the total fiber content for theabsorbent batt.

The fluid absorption characteristics and volume capacity of thesuperabsorbent fibrous material (as noted by the disclosure withincopending application of Messers. D'Elia and Hogan) are determined bymany factors including superabsorbent fiber content, the composition ofthe support fiber material, batt density, and padding size. It isrecognized also that the horizontal and vertical water retentionproperties of the absorbent fibrous layer will vary markedly withalterations in the nature and percentage content of superabsorbent fiberversus support fiber, the denier, the fabric weight, and the compositionof the support fiber. If and when the preferred blend of heterocycliccarbonate and copolymer of maleic anhydride and isobutylene is employed,polyester is the most desirable material for use as the support fiberfor combination with the superabsorbent fiber. Polyester polymerscontribute excellent absorbency properties adjunct and complementary tothose of the absorbent fibers themselves when present in sufficientdensity. Moreover, whenever finer denier of support polyester fibers isemployed, the overall fluid retention capacity is clearly increased suchthat various embodiments of the preferred materials are able to absorb60 fold and somtimes up to 100 fold their product weight of water orother fluid.

To illustrate and to understand how the preferred construction for thesuperabsorbent fibrous material works, FIG. 3 illustrates across-sectional view of the construct in greater detail. The supportfibers 24 are shown as solid lines while the superabsorbent fibers 22are provided as dashed lines so that they can be distinguished from oneanother. In the unused, dry state, both the superabsorption fibers andthe support fibers may criss-cross and bend as indicated within FIG. 2.When the absorbent batt absorbs liquid and becomes wet, thesuperabsorbent fibers 22 can swell to many times their original drysize, up to and including about 100 times their diameter when dry. Inaddition, the swelling of the superabsorbent fibers upon wetting exertsforce upon the support fibers 24 in the batt and stiffens them.Accordingly, in many instances, the absorbent batt forces fibers whichare only loosely crossed and meshed in the dry state to tightly lock andsupport each other in the wetted fluid absorbent state. This mechanismis believed to account in part at least for the superabsorptioncapability of the fibrous layer to retain its physical integrity evenwhen holding many times its weight in liquid.

It should be noted and appreciated also that a wide range and diversityof other compounds and chemical compositions are believed to beconventionally available and known as substitutes and replacements forthe preferred composition for superabsorbent fibers as described above.The range, variety, and diversity of such superabsorbent materials andcompositions is described within the following publications: waterabsorbing acrylic copolymer compositions prepared from acrylic acidmonomers and hydrophilic unsaturated carbonate monomers as describedwithin Japanese Patent Publication No. 63242344 (881017); the waterabsorptive composites of impregnated natural or synthetic fibers withmodified acrylic acid described within European Patent Publication No.290814 (881117); water-swellable cross-linked polymers ofvinyl-saccharide monomer as described by European Patent Publication No.283090 (880921); a superabsorbent for blood and proteinaceous fluidcomprising insoluble ionic macromolecular material in acidic form asdescribed within French Patent No. 2602985 (880226); water absorptivefibrous composite materials containing polymerized partially neutralizedacrylic acid which is cross-linked using glycidyl ether compounds asdescribed by European Patent Publication No. 232121 (870812);water-absorbing polymer compounds prepared by polymerization of acrylicacid (alkali metal) salts in the presence of alpha-olefins andcarboxylic acids as described within Japanese Patent Publication No.2053310 (870309); and a fluid absorbing composition comprising watersoluble carboxylic copolyelectrolyte cross-linked with di- orpoly-functional aziridine as described within U.S. Pat. No. 4,645,789.It will be recognized and appreciated that the provided listing ismerely illustrative and clearly non-exhaustive in its coverage. Manyother liquid absorbing materials able to be manufactured and to providea superabsorbent capability--that is, able to absorb at least 15 timesits own weight in liquid--are clearly available and commercially soldtoday. All such conventionally known chemical compositions,manufacturers, and superabsorbent fibrous materials are deemed to bewithin the scope of the present invention.

Chemical Agents Which May Be Optionally Combined With The SuperabsorbentFibrous Material

A variety of diverse chemical agents may be optionally combined with thesuperabsorbent fibrous material in the receiver of the present system.The chemical agents desirably include, but clearly are not limited to,the following: chemical initiators, chemical activators, and catalysts;neutralizing agents, buffers, and salts; germicidal agents includingstatic, cidal, and other anti-microbials of varying ranges andproperties; chelating agents and other complex forming reactants;enzymes, cofactors, and enzyme substrates; specific binding agents suchas antibodies and antigens; agglutinizing agents and flocculatingagents; monomers, copolymers, and homopolymers with or without specificcross-linking agents; various oxidizing agents and reducing agents;coupling agents, decoupling agents, and carriers for conjugateformation.

It will be recognized by the range and diversity of chemical reagentsand/or reactants optionally present with the superabsorbent fibrousmaterial comprising the receiver that an enormous diversity of chemicalreactions and chemical consequences are intended. It will be understood,however, that despite the diversity of chemical compositions employed,the variety of chemical reactions envisioned possible, and the range ofreaction products yielded, that all of these employ solely conventionalchemistry and chemical reactions well described and commonly understoodby persons ordinarily skilled in these technical areas. All of thesediverse chemical reactants and reagents are thus deemed to be within thescope of the present invention.

II. SOME PREFERRED EMBODIMENTS OF THE PRESENT RECEIVING SYSTEM

To merely illustrate the wide range of formats and constructionsavailable for the essential components comprising the conduit, themodulator unit, and the replaceable receiver of the present invention,four different preferred embodiments will be individually described. Itwill be expressly understood, however, that these preferred embodimentsare merely illustrative examples of the present receiving system as awhole; and are adduced here to demonstrate some of the various uses andapplications for the present invention under both in vivo and non-livingconditions.

Moreover, each of the preferred embodiments described in detailhereinafter tangibly exists as and functionally represents an effectiveanswer to and successful resolution of the two fundamental questionswhich determine and control the value of such systems. It will beexpressly noted and appreciated that each preferred embodiment allowsone to collect and dispose of the fluid matter without himself cominginto meaningful contact with or being detrimentally affected by thefluid matter during the process of collection and disposal; and eachpreferred embodiment also permits one to effectively collect and disposeof fluid matter without concomitantly influencing, contaminating, orotherwise altering the source from which the fluid matter originates. Byproviding these capabilities and achievements, the individual preferredembodiments and the receiving system as a whole have differentiated anddistinguished themselves from conventional practices and apparatus.

A. A System For The Receipt And Collection Of Drainage Fluid From ASurgical Incision In A Living Subject

The closed, fluid-modulating receiving system of the present inventionemployed in vivo for receiving drainage fluid from a surgical incisionin a living subject is illustrated by FIGS. 4 and 5. As seen therein,FIG. 4 illustrates the individual component parts when purposefullyseparated from one another for increased clarity. In comparison, FIG. 5shows the present receiving system as an integral whole and whenperforming its intended function with respect to a living subject.Accordingly, FIG. 4 will be recognized as being an artificial separationfor purposes of easier understanding and description while the systemillustrated within FIG. 5 illustrates the assembled drainage fluidreceiving system in proper position and in fluid communication with theinternal tissues of a living subject.

It will be recognized that the typical setting and intended usage forthe drainage fluid receiving system of FIGS. 4 and 5 is after a wound orsurgical incision has been made in the body of a living subject; and thesurgeon or physician has made a medical decision to insert a drain inthe wound or incision for an indefinite period of time in order that anyfluid which might accumulate around the open wound be removed ratherthan accumulate at that anatomical site. Typical instances of use wouldbe for draining pleural fluids from a diseased or collapsed lung and fordraining abdominal (ascites) fluid. Accordingly, a receiving system 30has been inserted into the surgical incision or wound 28 as appearswithin FIG. 5. The receiving system 30 comprises: a conduit formed as adrain 32 for draining fluids from a surgical incision in the body of aliving subject; a discrete modulator unit formed as a flow-throughprotective cap 40 which is in fluid flow communication with the drain32; and a replaceable receiver in the form of a receptacle 50 which isable to be placed in closed fluid flow communication with the drain 32via the protective cap 40.

The drain 32 is typically a flexible conduit having a closed elongatedbody of determinable dimensions and a tube-like configuration, aninternal lumen 34 for the flow of discharged fluid from the incision orwound, and two discrete open ends 36,38. The internalized end 36 ispositioned within the body of the living subject while the other openend 38 extends externally from the body of the living subject.

The protective cap 40, serving as the modulator unit for the system, isdisposed at the external open end 38 of the drain 32 and lies in closed,fluid-flow communication with the internalized open end 36 within thebody of the living subject. The protective cap 40 comprises a porousmatrix layer 42 and a connector channel 44. In this embodiment, theporous matrix layer 42 is the fluid-modulating element of the modulatorunit.

The porous matrix layer 42 occludes the entirety of the external openend 38 of the drain 32 from the ambient environment and thus istypically positioned adjacent to the external open end 38 itself. Theporous matrix layer 42 has a plurality of external and internal matrixsurfaces such that drainage fluid conveyed by the drain 32 from thesurgical incision in the body of the living subject can pass through theporous matrix layer as a resulting drainage fluid product while theambient environment can not pass through the porous matrix layer in theopposite direction.

As appears in FIGS. 4 and 5, the porous matrix layer 42 lies desirablyin the middle of the connector channel 44 which desirably has threadedends 46,48 (or some other means of connection) for direct junction withthe drain 32 and receptacle in a fluid-tight manner. While it is highlydesirable for the connector channel 44 to provide threaded ends forpurposes of forming a fluid-tight flow-through protective cap 40, anyconnector means which achieves fluid flow communication between theporous matrix layer 42 and the drain 32 is suitable for use.

Lastly, the receptacle 50 serving as the replaceable receiver of thesystem appears as a bottle-shaped article of determinable dimensions andvolume. The receptacle 50 serves as the container means for receivingand collecting the resulting drainage fluid product as it is dischargedfrom the porous matrix layer 42. As seen within FIGS. 4 and 5, the topof the bottle-shaped receptacle 50 is preferrably composed of a flexiblerubber or plastic substance and formed in part as a series of expandableand compressible ribs 52 and the collection container 54. The expandableand compressible ribs 52 are in fluid flow communication with the porouscap 40 and are preferably screw threaded in order to join directly withthe threaded end 48 of the connector channel 44. The expandable andcompressible ribs 52 also permit a person to pull or push the receptacle50 and thus provide a pumping action if necessary or desired to increasethe fluid flow rate from the protective cap into the receptable proper.

The internal volume of the receptacle 50 is at least partially filledwith a superabsorbent fibrous material 56 able to absorb at least 15times its own weight of liquid, and preferably is able to absorb between60-100 times its own weight of liquid. Thus, such resulting drainagefluid product as flows into the internal volume of the receptacle 50 isat least partially and most often entirely absorbed by thesuperabsorbent fibrous material 56.

In this drainage fluid receiving system 30, it is expected that thedrainage fluid itself will comprise blood, lymph fluid, mucous, ascitesfluid, peritoneal fluids, chest fluids, and the like--all of which areliquids produced by the body of the living subject; as well as varioussolid, cellular, and/or particulate matter from the tissues and organsof the living subject. It will be recognized and appreciated, therefore,that the modulating unit constructed as the protective cap 40 provides afluid-modulating element in the form of the porous matrix layer 42 whichacts upon the drainage fluid as it passes from the drain 32 into thereceptacle 50. The porous matrix layer 42 having the plurality ofexternal and internal surfaces and being porous allows the drainagefluid to pass through while preventing the ambient environment frompassing in return through the protective cap into the drain andsubsequently into the surgical incision or wound. The porous matrixlayer therefore prevents and reduces the risk of post-surgicalinfections and complications by preventing the ambient environment frommaking direct entry into the incision or wound via the drain, ascustomarily occurs in conventional practice.

Similarly, the receptacle 50, being in close fluid flow communicationwith the drain 32 via the protective cap 40, achieves a closed receiptand collection of drainage fluid; and absorbs the resulting drainagefluid product as it is received by the presence and effect of thesuperabsorbent fibrous material 56. In addition, in view of the natureand source of the resulting drainage fluid product itself, it is highlydesirable that at least one germicidal agent be present within theinternal volume of the receptacle 50 in order to diminish or eliminatethe potential infectious nature of the fluid itself. Thus, typically,the addition of a phenolic composition or an iodine containinggermicidal agent to the superabsorbent fibrous material in advance ofusing the receptacle or the receiving system provides highly desirablebenefits.

The receptacle 50, being replaceable at will or on demand, may beremoved and substituted by another similarly constructed receiver asneeded or required. It will be appreciated that during the limited timeperiod during which the substitution of receptacles is made by acompetent technician or nurse, that the drain 32 is itself completelyprotected from the ambient environment by the presence and effectivenessof the porous matrix layer 42 within the protective cap 40.Consequently, replacement of the receptacle 50 may be made without fearof accidentally contaminating the drain 32 or consequently affecting thesurgical wound or incision itself within the body of the living subject.If desired also, a self-sealing protective closure optionally may beinserted at the protective cap and/or the receptacle 50 to furtherensure the prevention of accidental contaminants or infections for theliving subject. In this manner, one may also optionally seal the systemto avoid changes in pressure (such as for a collapsed lung) whenchanging and/or replacing the receptacle.

Finally, it will be recognized and appreciated that this drainage fluidreceiving system provides for and successfully performs the twonecessary and fundamental goals. First, this drainage fluid receivingsystem allows for the collection and disposal of drainage fluid withoutany person coming into meaningful contact with or becoming detrimentallyaffected by the drainage fluid. Second, this drainage fluid receivingsystem concomitantly permits the effective collection and disposal ofdrainage fluid without influencing, contaminating, or seriously alteringthe medical condition and prognosis of the particular patient from whomthe drainage fluid was obtained. Thus, depsite the relative simplicityof its essential components and organization, this drainage fluidreceiving system is uniquely different from its conventionally knowncounterparts.

B. A System For Receiving Fluid From The Urinary Tract In A LivingSubject

The closed, fluid-modulating receiving system employed in vivo forreceiving fluid from the urinary tract in a living subject isillustrated by FIG. 6 as a transparent embodiment for purposes ofclarity. It will be recognized that the transparent format for thisembodiment is employed for descriptive purposes only; and that theurinary tract receiving system is suitable for incontinence, tumors, andpost-surgical use as well as for the particular application of relievingand removing accumulated urinary fluid from the bladder of a male orfemale living subject without regard to the health of the person.

For descriptive purposes only, a male subject appears within FIG. 6; andthe urinary fluid receiving system 70 has been internalized through thepenis 68 of the male subject and extended internally to reach theurinary bladder (not shown) in accordance with conventional practice forthis purpose. The urinary fluid receiving system 70 thus comprises aconduit formed as a flexible catheter 72 for removing fluid from theurinary tract of a living subject; a discrete modulator unit formed as aone-way, flow-through coupling 80 in fluid flow communication with thecatheter; and a replaceable receiver in the form of a collection vessel96 positioned in closed, fluid flow communication with the coupling andthe catheter.

The transparent nature and three-dimensional forms illustrated by FIG. 6reveal the catheter 72 to be a flexible conduit having an internal lumen74, an internalized open end 76 lying within the urinary tract of theliving subject, and an externalized open end 78 extending externallyfrom the penis of the living subject. The catheter 72, as well as theentirety of the receiving system 70, is preferably presterilized inadvance of usage and insertion within the urinary tract.

The coupling 80, serving as the modulator unit of the system, is formedas a one-way, flow-through article disposed at the external open end ofthe catheter 72 and lies in closed, fluid flow communication with theinternalized open end 76 positioned within the urinary tract. Thecoupling comprises a connector 82, a porous matrix layer 84, and anoptional but highly desirable unidirectional flow valve 86.Alternatively, the coupling may optionally comprise only the porousmatrix layer 84 and the connector 82 alone. Either embodiment willfunction equally well for purposes of the receiving system.

By the position of the coupling 80, the porous matrix layer 82 occludesthe entirety of the external open end 78 of the catheter 72 from theambient environment; and thus functions as a porous barrier protectingthe urinary tract of the living subject from accidental contamination orinfection. The porous matrix layer 82 has a plurality of external andinternal matrix surfaces such that urinary fluid from the living subjectcan pass through as a resulting urinary fluid product while the ambientenvironment is prevented from passing through the porous matrix layer.Accordingly, the porous matrix layer 82 serves as the fluid-modulatingelement; and physically acts upon the liquid state of the urinary fluidto yield a resulting urinary fluid product. If desired, a variety ofdifferent chemical substances may optionally be applied as a covering orcoating over the external and internal surfaces of the porous matrixlayer in order that one or more chemical reactions may also occur. Inthis manner, a pH sensitive dye reagent may be applied to the porousmatrix layer; and the resulting urinary fluid product will then exhibitand demonstrate a specific color reaction to the observer whichindicates the acidic or basic pH value of the fluid.

The optional unidirectional flow valve 86 lies within the connector 82and allows the resulting urinary fluid product discharged from theporous matrix layer 84 to pass through while prohibiting backflow in theopposite direction. The flow valve 86 is thus a "check" valve andfunctions as an aid within the system 70 to promote a single directionalflow of fluid. It will be recognized and appreciated that theunidirectional flow valve 86 may optionally comprise part of thecoupling 80 or, in alternative formats, may comprise an integral featureof the collection vessel 90 itself.

In its most preferred construction, the flow valve 86 provides aninterlocking series of blades 88, a retention chamber 90, and a samplingport 92. The retention chamber 90 provides for the retention of a smallvolume of fluid prior to exiting through the blades 88; and the samplingport 92 allows a technician or nurse to insert a syringe or othersampling device for the removal of aliquot volumes of the fluid prior toits flow into the collection vessel 96. All of these features within theunidirectional flow valve 86 are optional; and may be either employed oreliminated at the desire or needs of the user.

The collection vessel 96, serving as the replaceable receiver of thesystem, is a flexible container of determinable dimensions and internalvolume. The collection vessel 96 is positioned in closed, fluid flowcommunication with the catheter 72 via the coupling 80 and thus providesthe terminus for the system as well as the point of final collection.The collection vessel 96 thus serves as the means for receiving andcollecting such resulting urinary fluid product as is provided; andcontains at least one superabsorbent fibrous material able to absorb atleast 15 times its own weight of liquid. In this manner, such resultingurinary fluid product as flows into the collection vessel is absorbed atleast partially, if not entirely, by the superabsorbent fibrousmaterial.

The collection vessel 96 illustrated within FIG. 6 is configured toprovide several optional, but highly desirable features. The collectionvessel itself appears as a flexible receiver having an optional carryingstrap 100 which desirably allows the person to remain completely mobileeven while catheterized. In addition, an inlet 102 optionally allows atechnician or nurse to introduce volumes of a disinfecting chemicalagent such as bleach or a peroxide solution directly into the internalvolume of the collection vessel 96. The inlet 102 may also be employedfor the introduction of any other chemical reagent or reactant toaccommodate the desires or needs of the user.

It will be appreciated also that the collection vessel 96 is areplaceable receiver; and it is intended that periodic replacement ofthe collection vessel will be made over hours or days. During the timerequired for replacement of each collection vessel as necessary, it isclear that the porous matrix layer of the coupling, at a minimum,provides a physical barrier and desirable protection for the livingsubject in that the ambient environment (and all that it contains) isprevented from passing through the system into the urinary tract.

In addition, in view of the conventional practice regarding irrigationof the catheter 72 as a hygienic procedure to avoid and ensure theabsence of obstructions or blockages within the catheter 72 or theurinary tract itself, it is optional within the system to provide for aport of entry 106 in the externalized portion of the catheter for thispurpose of irrigation. This entry port 106 remains closed/sealed untilpurposely opened by an attendant to perform the irrigation procedure. Inthis manner, standard sterile saline or other irrigation liquid will beintroduced via the entry port 106 into the lumen of the catheter; act inthe customary way to irrigate the lumen and urinary tract; and serve toprevent potential obstruction in the catheter. The irrigation fluidintroduced into the catheter in this way will flow by gravity throughthe lumen towards the external open end of the catheter where it willmake contact with the porous matrix layer of the coupling. Theirrigation fluid will then itself pass through the external and internalsurfaces of the porous matrix layer and itself then flow through thecoupling and be received and collected subsequently within thecollection vessel. The irrigation fluid itself will then also beabsorbed in its entirety by the superabsorbent fibrous materialcontained within the collection vessel.

Finally, it will be noted and acknowledged that this urinary fluidreceiving system as a whole accomplishes and capably performs theunderlying two fundamental goals necessary for such sysstems. First,this urinary fluid receiving system achieves the receipt, collection,and disposal of urinary fluid without any person coming into meaningfulcontact with or becoming detrimentally affected by the urinary fluid.Second, this urinary fluid receiving system permits the effectivereceipt, collection, and disposal of urinary fluid without any risk ofinfluencing, contaminating, or altering the health or medical status ofthe particular person from which the urinary fluid was obtained.Therefore, despite its superficial similarity to its predecessors, thecapabilities and achievements of this urinary fluid receiving systemmeaningfully distinguish and substantively separate the present systemfrom all others.

C. A System For Receiving Fluid Fecal Matter From A Resected Bowel In ALiving Subject

A closed, fluid-modulating receiving system employed in vivo forreceiving fluid fecal matter from a resected bowel in a living subjectis illustrated by FIGS. 7-12 respectively. The fluid fecal matterreceiving system comprises: a conduit formed as a bowel retaining ringfor retaining the resected end of the bowel in a living subject forconveyance of fluid fecal matter from the living subject, the fecalmatter itself being fluid and composed of gaseous, liquid, and solidfecal constituents; a modulator unit formed as a flow-through, variablevolume diaphragm chamber 214 for removable juncture to and for fluidcommunication with the bowel retaining ring; and a receiver in the formof a flexible pouch and surrounding bandage 240 encompassing and inclosed fluid flow communication with the variable volume diaphragmchamber and the bowel retaining ring, this flexible pouch/surroundingbandage comprising porous membrane means for releasing such gaseousfecal material as flows into the flexible pouch into the ambientenvironment.

As seen within FIGS. 7 and 10, the receiving system 210 is intended forin vivo use with the resected bowel in a living subject after eitherileostomy or colostomy. The resected bowel end 200 typically extendsexternally from the side of the living subject after surgery in orderthat fluid fecal matter (including gaseous, liquid, and solid fecalmaterials) pass directly from the internal remainder of the bowel out ofthe body. Initially, as seen within FIGS. 7 and 10, a bowel retainingring 212 is positioned around the stroma of the resected bowel end 200extending externally from the body. The bowel retaining ring 212encompasses and retains the externalized portion (the stroma) of theresected bowel; and serves also as the point of physical attachment andanchorage for the other component parts of the receiving system. Thebowel retaining ring 212 is desirably composed of a soft but resilientsubstance; and is preferably a substance which offers some useful degreeof elasticity and flexibility while positioned on the resected bowel endso that the wearer will avoid both discomfort and/or irritation duringuse. Moreover, the bowel retaining ring can be sterilized either priorto or after use; and may periodically be replaced on an irregular orscheduled time basis.

The bowel retaining ring 212 is unique within this embodiment in that itachieves and provides for the conveyance of fluid fecal material fromthe living subject by encompassing the external surface of the resectedbowel itself. In this instance, the bowel retaining ring 212 functionsand serves as a structural connector and link without which the physicalpassage and transfer of fluid fecal matter would not otherwise occur.Furthermore, because the flow-through modulator unit and the replaceablereceiver of this embodiment are in fact joined to the bowel retainingring while in its intended position, it will be recognized andappreciated that the resected bowel end 200 extending from the livingsubject is actually inserted into and becomes encompassed by theremainder of the receiving system itself. This is clearly illustratedvia FIGS. 10, 11, and 12 collectively.

The variable volume diaphragm chamber 214 serving as the discrete,flow-through modulator unit of the system, is constructed for removablejuncture to and for closed fluid communication with the bowel retainingring 212 and the bowel end 200. The diaphragm chamber 214 comprises anexpandable and compressible housing 216; means within the housing forseparating solid fecal material from liquid and gaseous fecal materialin the conveyed fluid fecal matter; and means for removing the separatedliquid and gaseous fecal material from the diaphragm chamber as aresulting fecal fluid product. Detailed views of the variable volumediaphragm chamber 214 are illustrated by FIGS. 8A and 8B respectively.

FIG. 8A shows an overhead frontal view of the diaphragm chamber whileFIG. 8B shows a perspective, rear view of the diaphragm chamber. Thehousing 216 is an expandable and compressible construction formed by afront plate 218 and a back plate 220. The front and back plates 218,220are preferably formed of a flexible metal or resilient plastic; and aredesirably joined together along a common edge 222. The front plate 218has a small diameter inlet 224 which is desirably encircled and boundedby an elastic, fluid-tight closure 226. The back plate 220 contains alarge diameter outlet 228. Positioned within the front plate 218 and theback plate 220 are a plurality of apertures 230.

Within the interior volume of the housing 216 is a large pore netting232 which, at a minimum, covers the entirety of the outlet 228 anddesirably serves as a liner for the entirety of the internal volume ofthe housing. The netting 232 serves as the separation means within thehousing 216 for separating solid fecal material from liquid fecalmaterial and gaseous fecal material constituting the fluid fecal matterconveyed by the resected bowel 200 via the bowel retaining ring 212 intothe inlet 224. The netting 232 is desirably formed of the highly elasticmaterial, is flexible and extendable, and retains its tensile strengtheven while distorted. Moreover, during the separation of solid fecalmaterial, it is expected that the netting 323 will become so enlargedand distorted by the retention of solid fecal material; and that thenetting will be caused to extend physically through the outlet 228--allwithout tearing, fragmenting, or otherwise reducing its effectiveseparation capacity.

The variable volume diaphragm chamber 214, serving as the flow-throughmodulator unit of the system, is itself positioned and contained as adiscrete entity within a receiver of determinable dimensions and volumeconstructed desirably in the form of a flexible pouch with surroundingbandage 240. The positioning and placement of the diaphragm chamber 214within the flexible pouch 240 is illustrated by FIGS. 9, 10, 11, and 12.The flexible pouch 240 is constructed as an expandable/inflatablereceiver comprising at least a front wall 242 and a rear wall 244 joinedtogether along a common seam 246 via a fluid-tight seal. A set of bodystraps 248 are present to enable the living subject to wear the flexiblepouch and diaphragm chamber combination as a surrounding bandage withrelative ease. Note that the interior volume 250 of the flexible pouch240 holds and encompasses the diaphragm chamber 214 in its entirety.Accordingly, to properly accommodate and position the diaphragm chamberin its intended function, the front wall 242 contains an open portal 260whose diameter and configuration is coextensive with the inlet 224 andinlet closure 226 of the diaphragm chamber 214. As shown by FIG. 9 inparticular, the inlet 224 and closure 226 are visible and extend throughthe portal 260 of the front wall 242. In this manner, any and all fluidfecal matter passing through the portal 260 immediately enters theinterior of the housing 216 of the diaphragm chamber 214 as it proceedsbefore passing into the remainder of the interior volume 250 within theflexible pouch/bandage 240. In this construction, therefore, no fluidmatter can enter the interior of the flexible pouch without firstpassing through the diaphragm chamber 214.

The rear wall 244 is illustrated by FIG. 12 and includes at least onegas permeable and liquid impermeable porous membrane 270 which is joineddirectly to and thus forms an integral part of the rear wall itself. Theporous membrane 270 provides a plurality of external and interiormembrane surfaces through its thickness; and has the property ofallowing the passage of gases and vapors while prohibiting the passageof liquids or solids. Such porous membranes are deemed "gas permeable";and are commercially available. It will be appreciated that a variety ofdifferent compositions and constructions of such gas permeable porousmembranes are known including organic and inorganic substancesindividually and in mixture. For purposes of the present invention, thetrue composition and mode of preparation for the membrane material, thetrue pore size, the total porosity and void volume, and the degree towhich gases are permitted to pass through the membrane is of noimportance or consequence whatsoever. To the contrary, so long asgaseous fecal materials are permitted to pass through the porousmembrane and released from the interior of the flexible pouch/bandagevia the porous membrane while concurrently prohibiting and retaining allliquids and/or solids, all such gas permeable/liquid impermeable porousmembranes are deemed to be within the scope of the present invention.

In addition, within the internal volume 250 of the flexible pouchbandage 240; and filling in particular the volume space between the backplate 220 and netting 232 of the diaphragm chamber 214 and the gaspermeable porous membrane 270 of the rear wall 244 of the flexible pouch240; is a quantity of a superabsorbent fibrous material 280 which isable to absorb at least 15 times, and preferably 60-100 times its ownweight of liquid. The majority of the interior volume 250 of theflexible pouch/bandage 240 is thus at least partially, and preferablyentirely filled, with the superabsorbent fibrous material 280. In thismanner, any and all liquid fecal material coming into contact with theinternal volume of the flexible pouch is absorbed at least partially ifnot entirely by the superabsorbent fibrous material 280.

Having described each of the component parts of the fluid fecal matterreceiving system individually, it is deemed for purposes of clarity andcomprehensive understanding to follow the course and flow of fecalmaterial discharged from the living subject into the receiving system.Accordingly, the resected bowel end 200 is placed through the bowelretaining ring 212 as illustrated by FIG. 7. Clearly, there is expectedto be a minimal length of resected bowel for this purpose; and the bowelretaining ring 212 typically will be positioned adjacent to and abuttthe side of the living subject. The flexible pouch/bandage 240encompassing and containing the diaphragm chamber 214 is then joined tothe bowel retaining ring 212 in the manner shown by FIG. 10. As seentherein, the resected bowel end 200 penetrates and extends partiallyinto the diaphragm chamber and thus concomitantly enters into theinterior volume of the flexible pouch. Physical juncture is made via theinlet 224 and closure 226 of the diaphragm chamber which are disposedupon and attached to the bowel retaining ring 212 thereby forming afluid-tight connection. The straps 248 of the flexible pouch 240 aredesirably tied snuggly around the body of the living subject such thatfirm abuttment and close proximity without major movement are maintainedbetween the resected bowel end of the living subject and the whole ofthe fluid fecal matter receiving system 210.

Fluid fecal matter discharged through the alimentary canal of the bowelflows through the resected bowel end 200 which is in fluid flowcommunication directly with the housing 216 of the diaphragm chamber214. The netting 232 of the diaphragm chamber separates the liquid andgaseous fecal constituents; and retains the solid fecal materialentering the diaphragm chamber such that the retained solid fecalmaterial is held partially within the housing 216 and partially withinthe lumen of the resected bowel itself. The separated liquid and gaseousconstituents of the fluid fecal matter fractioned by the netting 232tend to flow in different and alternative directions. The gaseous fecalmaterial, once separated, tends to flow directly through the nettingthrough the outlet 228 of the diaphragm chamber 214 and then encountersthe superabsorbent fibrous material 280 filling the interior volume ofthe flexible pouch/bandage 240. The superabsorbent fibrous material280--being itself porous--allows and permits the fecal gases to passdirectly through until the gases reach the rear wall 244 and the gaspermeable porous membrane 270. Typically, however, some, but not all, ofthe gaseous fecal material will then pass through the porous membrane270 into the ambient environment. The residual portion of the gaseousfecal material then remaining within the internal volume 250 of theflexible pouch 240 are temporarily contained within the superabsorbentfibrous material 280. However, when the person moves, walks, or sitsdown, the movement and/or weight of the person will be thrust directlyagainst the internal contents of the flexible pouch/bandage--therebyforcing the residual gaseous fecal material through the porous membrane270 under considerable compression force. In this manner, substantiallyall of the gaseous fecal material separated by the diaphragm chamber 214is released ultimately over time into the ambient environment.

The liquid fecal material separated by the netting 232 of the diaphragmchamber 214 is directed through the housing 216 and flows through theapertures 230 into the rest of the internal volume of the flexiblepouch/bandage 240. The separated liquid fecal material passing throughthe apertures 230 thus come into direct and intimate contact with thesuperabsorbent fibrous material 280 filling the interior volume of theflexible pouch; and the liquid fecal material becomes absorbed at leastin part (if not entirely) by the superabsorbent fibrous material.Similarly, when the person moves, walks, or sits down, the body of theperson presses against and consequently compresses the housing 216 ofthe diaphragm chamber 214--thereby forcing the separated liquid fecalmaterial to pass by compression force through the apertures 230 and alsothrough the outlet 228 of the housing into the volume space filled bythe superabsorbent fibrous material 280. In this manner, the separatedliquid is periodically expelled from the diaphragm housing 214 undercompression force by the normal movements of the living subject; and isquickly absorbed by the superabsorbent fibrous material as aconsequence. Moreover, when the person rises or markedly changesposition, the housing 216 then expands back into its original volume andconfiguration; and again provides a greater capacity for additionalfluid fecal matter to be received, separated, and collected by thereceiving system.

It will be appreciated in particular that the compressible andexpandable housing 216, the apertures 230, and the netting 232collectively provide and serve as the fluid-modulating element of thediaphragm chamber 214 in this embodiment. Thus, all fluid fecal materialflowing from the resected bowel end of the living subject is acted uponby the diaphragm chamber 214 to yield a resulting fecal fluidproduct--which is collectively the separated and retained solid fecalmaterial; the separated and subsequently absorbed liquid fecal material;and the separated gaseous fecal material subsequently released into theambient environment. Moreover, it will be recognized that the variablechamber 214 is an essential component positioned within the internalvolume of the flexible pouch itself. Thus, in this fluid fecal matterreceiving system, when the receiver is periodically replaced, themodulator unit itself is concomitantly replaced as well.

Furthermore, in this embodiment, recognizing that fecal matter--whethergaseous, liquid, or solid--is malodorous if not actually organicallyoffensive, it is most desirable that one or more gas-deodorantcompositions optionally be added to the superabsorbent fibrous materialwithin the internal volume of the flexible pouch/bandage. Thesegas-deodorant compositions would therefore serve two different functionsand purposes. First, these substances would deodorize such gaseous fecalmaterial as is released from the diaphragm chamber and passes throughthe superabsorbent fibrous material prior to being released into theambient environment via the gas permeable porous membrane. The releaseof a deodorized gas would be very socially desirable and pleasant forthe living subject. Second, the deodorization of the liquid fecalmaterials absorbed by the superabsorbent fibrous material would minimizethe presence of malodorous substances retained within the flexiblepouch/bandage. The presence of deodorizing agents would reduce thediscomfort typically experienced by the living subject as a result ofwearing and using conventionally known ileostomy/colostomy bags.

Finally, it will be perceived and acknowledged that this fluid fecalmatter receiving system as a whole affirmatively answers andsuccessfully resolves the two fundamental issues underlying anddetermining the true use and value of such systems. First, this fluidfecal matter receiving system provides for the receipt, collection,separation, and ultimate disposal of fecal matter without any personbeing placed at risk or becoming detrimentally affected by the fecalmatter. Second, this fluid fecal matter receiving system performs theeffective receipt, collection, and disposal of fluid fecal matterwithout meaningfully influencing, contaminating, or seriously alteringthe health and medical status of the ileostomy/colostomy patient fromwhom the fecal matter must be removed. Thus, the present system isdemonstrably different and distinguishable from its predecessors byvirtue of these singular achievements.

D. A System For Receiving A Hazardous/Toxic Fluid From An InanimateSource

A closed, fluid-modulating system for receiving and collecting ahazardous/toxic fluid from an inanimate source is illustrated by FIG.13. By definition, a hazardous fluid is a substance which posespotential danger to the health and safety of the public because of itsinherent properties. Substances are considered hazardous if they areirritating, corrosive, flammable, capable of producing combustiblevapors, pyrophoric, unstable, or capable of rapid release of energy. Theterm includes wastes, chemicals, and materials generally without regardto composition. In comparison, a toxic fluid represents the lethalcapacity of a substance and is recognized by its capacity to causetissue damage, disease, or death to a living subject. The degree oftoxicity depends on the dosage and route of exposure of the substance(whether by ingestion, inhalation, or through contact with the skin).Acute toxicity refers to the effects of a single intense exposurewhereas chronic toxicity refers to the cumulative effect of repeatedexposure to various amounts of the agent over a longer time frame. Forpurposes of the present invention, the terms hazardous and toxic areused interchangably while retaining their individual connotative anddenotative meanings.

The embodiment of the present invention which is a hazardous/toxic fluidreceiving system comprises: a conduit formed as a non-reactive pipe forconveying a hazardous/toxic fluid from its source; a discrete modulatorunit formed as a one-way flow-through union disposed at one open end ofthe pipe and being in fluid flow communication with the source of thehazardous/toxic fluid; and a receiver of determinable dimensions andvolume in the form of a holding tank capable of being placed in fluidflow communication with the pipe via the union, at least onesuperabsorbent fibrous material being disposed within the holding tankfor absorbing such fluid as flows into the holding tank.

The typical use circumstances and applications for this embodiment ofthe present invention are particularly desirable in pathologylaboratories of hospitals, mortuaries, dry cleaning establishments andprocessing factories, and any other site or place where hazardous ortoxic fluid materials are employed. In the pathology laboratory and themortuary, formaldehyde, typically in the form of aqueous formalin, isfrequently employed both as a preservative and as a disinfecting agent.Formaldehyde and formalin are recognized hazardous chemicals whosecollection and disposition is how being regulated by various state andfederal agencies. Similarly, in far more commonplace situations as thedry cleaning industry, a variety of different toxic fluids such asmethylene chloride, chloroform, carbon tetrachloride, and various otherketones and benzene derivatives are employed routinely. All these agentsare recognized toxic fluids; and their handling as well as theircollection and disposal is a matter of the greatest importance to thehealth and safety of the public at large as well as to the workers inthe industry.

For purposes of describing the present embodiment, therefore, a singleuse situation will be described which for illustrative purposes onlywill be limited to the use of formalin as a preservative in the mortuaryand funeral industry. Accordingly, as seen in FIG. 13, a shallowembalming table 300 for holding the corpse or other remains of a subjectis constructed in fluid flow communication with the hazardous/toxicreceiving system comprising the present invention. The table 300 isgenerally an open volumetric container having a sieve 302 for drainageof fluids. Typically, the corpse is placed on the table 300 and hisbodily fluids drained and replaced by a formalin solution. All thedrained body fluids as well as a certain quantity of the aqueousformalin are contained within the embalming table and flow through thesieve into the receiving system.

Directly joined to the embalming table 300 and the sieve 302 is aconduit formed as a non-reactive pipe 310. One open end of the pipe 310is joined directly to the table 300 via the sieve 302. The other openend of the pipe 310 is in direct fluid communication with a discretemodulator unit formed as a one-way, flow-through union 320 disposed atthe other open end of the pipe.

The union is in fluid flow communication, therefore, with the table 300and the corpse which is being filled with aqueous formalin prior toburial. The union comprises a porous matrix layer 322 which occludes theentirety of the open end of the pipe 310; and a connector 324 whichserves as the means for fluid flow communication between the porousmatrix layer 322 and the remainder of the receiving system. Aspreviously described and employed in earlier embodiments herein, theporous matrix layer 322 has a plurality of external and internal matrixsurfaces such that the hazardous/toxic fluid can pass through the porousmatrix layer as a resulting fluid product while the ambient environmentcan not pass through the thickness of the porous matrix layer. Theconnector 324 is desirably a cylindrical-shaped article and preferablyhas screw threads at either end such that a fluid-tight juncture can bemade with the pipe 310 and the subsequently positioned replaceablereceiver.

An optional, but often highly desirable, feature not illustrated withinFIG. 13 is the addition and presence of a unidirectional flow valvewhich allows the resulting fluid product to pass through whileprohibiting any back flow of the fluid product. When present, thisunidirectional flow valve would be positioned in-line below the porousmatrix layer 322 and preferably housed within the connector 324. It willbe recognized, however, that this is merely an optional feature tofurther protect the security of the persons working in this environment.

Another optional feature to be employed in combination with theflow-through union 320 is the optional inclusion and use of one or morechemical reactants or reagents which would react in a recognized mannerwith the aqueous formalin either before or after its passage through theporous matrix layer 322. In these circumstances, it is often desirableto dispose the chemical reagent or reactant directly upon the externaland internal surfaces of the porous matrix layer itself in aconventionally known manner. This would provide not only a usefulpositional site for the chemical substance but also provide a physicalsupport for the chemical action to proceed while the fluid travelsthrough the external and internal surfaces of the matrix layer itself.

The third essential component of this embodiment is the replaceablereceiver which is formed as a holding tank 330 and is in fluid flowcommunication with the union 320, the pipe 310, and the tub 300. Theholding tank 330 appears as a large capacity drum within FIG. 13; and isconstructed of resilient material in substantially cylindricalconfiguration having a typical 55 gallon volume. Alternatively, theholding tank may take form as any configuration of determinabledimensions and provide any volume which is desirable or useful for thatparticular application.

The holding tank comprises a container which serves as the tangiblemeans for receiving and collecting the resulting fluid product releasedfrom the union; and at least one superabsorbent fibrous material fillingthe internal volume of the holding tank at least in part and able toabsorb at least 15 times its own weight of liquid. An optional buthighly desirable feature of this embodiment is the presence also of atleast one recognized neutralizing agent within the holding tank for atleast partial neutralization of such resulting fluid product as isabsorbed by the superabsorbent fibrous material.

As seen within FIG. 13, the holding tank 330 comprises thecylindrical-shaped container 340 which is at least partially filled witha superabsorbent fibrous material 350. The optional but highly desirableneutralizing agent is dispersed within the internal volume of thecontainer 340; and lies intermixed with the superabsorbent fibers withinthe holding tank proper. Since the hazardous/toxic fluid forillustrative purposes is aqueous formalin which passes through theporous matrix layer as a resulting fluid product; and becomessubsequently absorbed (at least in part if not in its entirety) by thesuperabsorbent fibrous material, it is desirable to include twodifferent chemical agents within the holding tank for purposes ofachieving at least partial neutralization. These chemical agentsdesirably are hydrogen peroxide and sodium carbonate. The interaction ofthese chemical agents with the resulting fluid product would chemicallyalter and at least partially neutralize the hazardous/toxic propertiesof the formalin in comparison to those recognized in its original,unaltered state.

In this manner, any and all formalin as well as other tissue fluidsremoved from the corpse lying within the embalming table flows directlythrough the pipe 310 and the porous matrix layer 322 of the union 320for subsequent receipt and collection by the holding tank 330. Thesuperabsorbent fibrous material 350 within the holding tank then absorbsmost if not all of the formalin; and, given the presence of one or moreoptional neutralizing agents, is able to at least partially neutralizethe hazardous and toxic properties of the ultimately absorbed fluidproduct. The holding tank 330 being replaceable, may then be removed asneeded or desired by the user for final disposition in an approvedmanner. During the replacement of the holding tank, the presence of theporous matrix layer 322 prevents the ambient environment from passingthrough the totality of the receiving system and thus enhances andensures the safety and protection of the persons working in the mortuaryor funeral home.

Thus, the present hazardous/toxic fluid receiving system directlyaddresses and satisfactorily resolves the two fundamental underlyingissues. First, this receiving system provides for the receipt,collection and subsequent disposal of hazardous and/or toxic fluidswithout any person being placed at serious risk or becomingdetrimentally affected by the fluids. Second, the present receivingsystem performs the effective receipt, collection, and disposal ofhazardous and/or toxic fluids without meaningfully influencing,contaminating, or otherwise altering the source from which the fluidsoriginate. These attributes and achievements clearly separate anddistinguish the present system from any and all superficially similarprocesses and apparatus.

The present invention is not to be restricted in form nor limited inscope except by the claims appended hereto.

What I claim is:
 1. A closed system for receiving fluid fecal matterfrom a resected bowel in a living subject, said fluid fecal matterreceiving system comprising:a bowel retaining ring for retaining theresected end of the bowel in a living subject for conveyance of fluidfecal matter from the subject, said fluid fecal matter comprisinggaseous, liquid and solid fecal material; a diaphragm chamber forremovable juncture to and for fluid flow communication with said bowelretaining ring, said diaphragm chamber comprisingan expandable andcompressible housing, separation means within said housing forseparating solid fecal material from liquid fecal material and gaseousfecal material in the conveyed fluid fecal material, and means forremoving said separated liquid material and gaseous fecal material fromsaid housing as a resulting fecal fluid product; and a flexible pouchencompassing and in closed fluid flow communication with said diaphragmchamber, said flexible pouch comprisingcontainer means for receiving andcollecting said removed resulting fecal fluid product comprising liquidfecal material and gaseous material, at least one superabsorbent fibrousmaterial within said container means said superabsorbent fibrousmaterial comprising absorbing fibers which absorb at least 15 timestheir own weight of liquid, such liquid fecal material as flows intosaid container means being at least partially absorbed by saidsuperabsorbent fibrous material, and porous membrane means for releasingsuch gaseous fecal material as flows into said container means, saidgaseous fecal material being releasable into the ambient environmentfrom said container means after passage through at least some of saidsuperabsorbent fibrous material within said container means.
 2. Thefluid fecal matter receiving system as recited in claim 1 wherein saidbowel retaining ring is composed of a soft but resilient substance. 3.The fluid fecal matter receiving system as recited in claim 1 whereinsaid bowel retaining ring is composed of an elastic and flexiblesubstance.
 4. The fluid fecal matter receiving system as recited inclaim 1 wherein said expandable and compressible housing of saiddiaphragm chamber is at least partially formed of a substance selectedfrom the group consisting of flexible metals and resilient plastics. 5.The fluid fecal matter receiving system as recited in claim 1 whereinsaid separation means of said diaphragm chamber is a large pore netting.6. The fluid fecal matter receiving system as recited in claim 1 whereinflexible pouch is expandable or inflatable.
 7. The fluid fecal matterreceiving system as recited in claim 1 wherein said flexible pouchfurther comprises a set of body straps joined to said container means.8. The fluid fecal matter receiving system as recited in claim 1 whereinsaid porous membrane means of said flexible pouch is permeable to gasesand impermeable to liquids.
 9. The fluid fecal matter receiving systemas recited in claim 1 wherein said superabsorbent fibrous materialcomprises absorbent fibers and support fibers.
 10. The fluid fecalmatter receiving system as recited in claim 1 wherein saidsuperabsorbent fibrous material absorbs up to 100 times its own weightof liquid.
 11. The fluid fecal matter receiving system as recited inclaim 1 wherein said flexible pouch further comprises at least onechemical reactant selected from the group consisting of chemicalinitiators, chemical activators, catalysts, neutralizing agents,buffers, salts, germicidal agents, antimicrobials, chelating agents,enzymes, cofac tors, enzyme substrates, specific binding agents,aggultinizing agents, flocculating agents, oxidizing agents, reducingagents, coupling and decoupling agents, and carriers for formingconjugates and complexes.